Zimmer Hip Implant Recall
The Zimmer Durom Cup was available in the U.S. for only two years but may have led to thousands of serious injuries in recipients. Comparisons with patients with the Durom system to those with more traditional hips and found that the revision rate requiring surgical repair was extremely high for the Durom Cup. The company was forced to recall the Durom Cup in 2008 and never returned the product to market.
Durom Cup Failures
Though Zimmer initially dismissed complaints about the Durom Cup as a problem caused by the surgeons who were placing the devices, surgeons noted that the device was prone to fail and slip out of position. Many patients required revision surgery, often within the first year after placement. Authors of one study comparing Durom cup patients to other hip replacement recipients concluded that the design was faulty.
Zimmer Hip Recall
Zimmer Biomet is an orthopedics company that specializes in designing joint replacement technologies which was created after the Zimmer company purchased its competitor, Biomet. Zimmer has designed a number of hip replacement prosthesis products, as did Biomet. While some of both Zimmer and Biomet’s products have been successful, others have troubled track records which have caused serious injuries to thousands of patients.
Specifically, Zimmer’s Durom Cup hip replacement product led to the Zimmer hip replacement recall and Biomet has faced issues over its Magnum M2A hip implant which has not been recalled. More recently, Zimmer Biomet was forced to recall certain model numbers of Zimmer M/L taper with Kinectiv technology femoral necks and stems.
Durom Cup Failures
The Durom Cup is a hip replacement product which the FDA approved for use in 2006 and was only on the market for about two years. It was used in total hip replacement operations, where a significant amount of bone is removed from the hip socket, and “ball” at the top of the femur and is replaced with artificial materials.
The Durom Cup is placed in a hip replacement procedure to be the “socket” liner of the hip joint. It was constructed out of metal alloy and is used in a metal-on-metal (MoM) hip joint replacement system. This all-metal hip replacement system was constructed in an effort to increase the lifespan and flexibility of artificial hips. However, for many patients who had a Durom Cup installed in their hip, there have been more drawbacks from the all-metal Durom Cup than benefits.
The troubling side effects of the Durom cup were first brought to the medical community’s attention by the orthopedic surgeon Larry Dorr in April of 2008. In a letter to the American Association of Hip and Knee Surgeons, Dorr made note of the high failure rates he was experiencing with the Durom Cup. Dorr reported that of 165 hip replacement surgeries he had performed using the Durom Cup, 14 had necessitated a revisionary surgery to replace the cup.
In Dr. Larry Dorr’s opinion, the failure of the Durom Cup in replacement hips was a result of faulty construction. The Durom Cup did not seal correctly in the hip socket and as a result, it often came detached from the hip socket of patients within the first few years of replacement surgery. Often this detachment proved very painful and immobilizing for patients. Once detached, the metal apparatus of the Durom Cup could move around and rub on the bone of the hip socket, causing agonizing pain.
These side effects generally begin approximately a year after hip replacement and often worsened to the point where mobility was significantly compromised and required revision surgery.
Durom Cup Hip Replacement Recalls
The Zimmer Durom Cup hip replacement recall came about as a result of the serious side effects which can follow installation of the metal liner. In 2007, Dr. Larry Dorr contacted both the FDA and Zimmer Incorporated in order to warn them of the problems associated with the Durom Cup. The response from Zimmer was that the failed Durom hip replacements were a result of improper installation by surgeons, not because of improper design by Zimmer.
Though Zimmer initially claimed that failures of Durom Cup placements were a result of improper installation by surgeons, Zimmer recalled the devices in July of 2008. During the Zimmer hip replacement recall, Zimmer stated that they were voluntarily removing the Durom Cup from the market in order to update the labeling of the product and supply additional installation training to surgeons, but the product was never returned to market.
Separately, prior to acquisition by Zimmer, Biomet had recalled devices in the early 2000s but never issued a recall for one of its most troublesome products, the M2A Magnum hip device. Zimmer Biomet has however, recalled a number of models of the M/L taper with Kinectiv technology necks and stems over concerns of excessive metallic debris. Complications from this recall have not yet been identified.
Zimmer Hip Lawsuits
Despite Zimmer’s initial claims that surgeon placement was at fault in Durom Cup failures, many orthopedic surgeons believe that the failings of the Durom Cup are actually a result of flaws in the cup’s design, not inadequate surgical technique. In the aftermath of the Zimmer hip replacement recall, a number of lawsuits have been filed by patients against Zimmer.
Zimmer set up a $69 million fund to compensate patients who have suffered damages as a result of faulty Durom Cup hip installations. Most of the lawsuits have been settled by some may remain in court systems.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.